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Scientists track spondyloarthritis in families to uncover clues to severe disease

NCT ID NCT01422694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 15 times

Summary

This study follows up to 2,000 people with spondyloarthritis (a group of inflammatory joint and spine conditions) and their healthy relatives. Researchers aim to identify symptoms, genetic factors, and medical tests that predict who will develop more severe forms of the disease. Participants undergo physical exams, imaging, and lab tests, but no treatment is given. The goal is to better understand the disease's natural history and improve future care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors predict which patients are at risk for severe spondyloarthritis and guide earlier, more personalized care.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and findings may take years to confirm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2011

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children and adults with spondyloarthropathies.

Ages

2 to 99 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: To be eligible for follow-up visits, patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center. * Subjects with known or suspected SpA. * Family members of individuals with known or suspected SpA. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy. * Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will be 6 years of age or older, and not pregnant. * Minor healthy volunteers undergoing imaging (SI and/or WB MRI) must be old enough to complete the procedure without sedation. Generally this requires that they be at least 6 years of age, so no healthy volunteers under age 6 will be enrolled. * Pregnant people with SpA are allowed to enrolled. Pregnant people will not be asked to undergo an MRI and will not be asked to submit to skin biopsy or bone marrow aspiration. EXCLUSION CRITERIA: * In the case of minors, unavailability of a parent or guardian to provide informed consent. * Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study. * Unavailability, or inability to comply with the schedule for follow-up visits. * Children under the age of 2 years old. The vast majority of minors with SpA or suspected SpA will be 6 years of age or older. However, it is possible that children younger than age 6 will be evaluated. If children under age 6 are referred for evaluation, we will ensure that they do not have any acute or chronic comorbidity that would preclude them from being safely evaluated at the NIH Clinical Center. Such patients would be referred to other appropriate pediatric hospitals. Based on estimates of the incidence and prevalence of SpA in the pediatric and adult populations we set the accrual ceiling up to 2000. We hope to enroll up to 100 patients per year. Fecal Microbiota Study INCLUSION CRITERIA: 1. Subjects must be enrolled on another NIH natural history protocol, including either 14-AR-0200 (Studies on the Natural History, Pathogenesis and Outcome of Idiopathic Systemic Vasculitis, P. Grayson PI); 18-AR-0081 (Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still s Disease and Related Inflammatory Conditions, M. Ombrello PI), or 94-E-0165 (Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies, Lisa Rider PI), and meet the respective protocol s criteria for a diagnosis of systemic vasculitis, systemic juvenile idiopathic arthritis, or dermatomyositis. 2. Subjects with definite SpA enrolled on 11-AR-0223 are eligible for the Fecal Microbiota sub-study. 3. Healthy volunteers and pregnant people enrolled on the above protocols are also eligible. EXCLUSION CRITERIA: 1. Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian. 2. Presence of any medical condition that would, in the opinion of the investigators, expose subjects to more than minimal risk, or confuse the interpretation of the study. 3. Subjects (including healthy volunteers) less than 4 years of age are excluded due to the challenging practical considerations of collecting stool samples, and because spondyloarthritis is much less common in this age group.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.